Device Classification Name |
Bandage, Liquid
|
510(k) Number |
K895819 |
Device Name |
MODIFIED LABELING TO THE SPAND-GEL GRANULATED GEL |
Applicant |
MEDI-TECH, INC. |
26 COURT ST. |
BROOKLYN,
NY
11242
|
|
Applicant Contact |
HERBERT A PERRY |
Correspondent |
MEDI-TECH, INC. |
26 COURT ST. |
BROOKLYN,
NY
11242
|
|
Correspondent Contact |
HERBERT A PERRY |
Regulation Number | 880.5090
|
Classification Product Code |
|
Date Received | 09/29/1989 |
Decision Date | 11/02/1989 |
Decision |
SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS
(SN) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General & Plastic Surgery
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|